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Carotid Artery Thickness in HIV Infected and Uninfected Adults

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ClinicalTrials.gov Identifier: NCT00007319
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : September 17, 2008
Information provided by:

Study Description
Brief Summary:
The intima-media thickness (IMT) test is a low cost, non-invasive way to measure the thickness of the carotid artery (the large artery in the neck). The purpose of this study is to compare the thickness of the carotid artery among HIV infected adults taking protease inhibitors (PIs), HIV infected adults not taking PIs, and HIV uninfected adults, and to examine how the thickness may change over time.

Condition or disease
HIV Infections HIV Seronegativity Atherosclerosis

Detailed Description:

Determination of clinical, lipid, and non-lipid risk factors has been the traditional approach for gauging an individual's risk for coronary artery disease (CAD). However, the IMT test, which uses sound waves to measure the thickness of the carotid artery, has been found to diagnose CAD and predict a person's risk for heart disease as well as or better than lipid and non-lipid risk factors. This study will use the IMT test to see if anti-HIV treatment and HIV infection affect a patient's risk of developing atherosclerosis (hardening of the arteries) by comparing carotid artery thickness among HIV infected adults taking PIs, HIV infected adults not taking PIs, and HIV uninfected adults.

There are 3 groups in this study. Group 1 will comprise HIV infected participants currently taking a PI-containing regimen. Group 2 will comprise HIV infected participants who are not taking PIs. Group 3 will comprise HIV uninfected participants. At each site, participants will be enrolled by "triads" consisting of an individual from each group. Each member of the triad will be closely matched by gender, age, smoking and menopausal status, race, and normal or hypertensive blood pressure. All 3 members of the triad must be identified before participants are registered to the study.

All participants will visit the clinic at Weeks 1, 24, 48, 72, 96, and 144 (3 years). At each visit, participants will have a physical exam, medical history and waist/hip ratio assessment, blood collection, and an IMT test. The absolute value for carotid IMT will be compared among the 3 groups. Viral load and CD4 counts will also be measured in Group 1 and 2 participants.

Study Design

Study Type : Observational
Estimated Enrollment : 132 participants
Time Perspective: Prospective
Official Title: Carotid Artery Intima-Media Thickness in HIV-Infected and Uninfected Adults: A Pilot Study

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria for Group 1

  • HIV infected
  • Have taken at least 1 PI continuously for 2 or more years and are currently taking at least 1 PI. Stopping therapy for 4 weeks or less for management of side effects or to change therapy is allowed.
  • Viral load of 10,000 copies/ml or less

Inclusion Criteria for Group 2

  • HIV infected
  • Not currently receiving PIs or have not taken PIs in at least 3 months
  • Not planning to initiate PI therapy in the few months following study entry
  • Viral load of 10,000 copies/ml or less
  • If not currently on anti-HIV treatment, must have been on treatment for at least 6 months in the past

Inclusion Criteria for Group 3

  • HIV uninfected

Exclusion Criteria for All Groups

  • Diabetes or current use of oral medications for diabetes
  • Kidney disease
  • ALT or AST greater than 2.5 times the upper limit of normal
  • Hypothyroidism
  • Family history (parents, brothers, sisters, or children) of heart attacks before age 55 in males and age 65 in females
  • Alcohol or drug abuse
  • Pregnant or plan to become pregnant during the study
  • Body mass index (BMI) greater than 30
  • Systemic chemotherapy or radiation therapy
  • Systemic steroids (prednisone or equivalent) at doses greater than 5 mg/day for more than 30 consecutive days
  • History of coronary heart disease or stroke (including chest pain, heart attack, or abnormal stress test)
  • Uncontrolled hypertension
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007319

United States, California
Kaiser Foundation Hosp
Harbor City, California, United States, 90710
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Los Angeles, California, United States, 90095
Univ of California, San Diego
San Diego, California, United States, 92103
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Judith S. Currier, MD, MSc University of California, Los Angeles
Study Chair: Howard N. Hodis, MD Atherosclerosis Research Unit, University of Southern California
More Information

ClinicalTrials.gov Identifier: NCT00007319     History of Changes
Other Study ID Numbers: ACTG A5078
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: September 17, 2008
Last Verified: May 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Protease Inhibitors
Risk Factors
HIV Seronegativity
Anti-HIV Agents
Carotid Artery
Tunica Intima

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases